Varenicline
Generic Name: varenicline
Brand Names:
Varenicline
11 DESCRIPTION Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a White to off-white to slightly yellow solid with the following chemical name: 7, 8, 9,10-tetrahydro-6,10-methano-6 H -pyrazino[2,3-h][3]benzazepine L-(+)- tartarate. It is freely soluble in water and very slightly soluble in methanol.
Overview
11 DESCRIPTION Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a White to off-white to slightly yellow solid with the following chemical name: 7, 8, 9,10-tetrahydro-6,10-methano-6 H -pyrazino[2,3-h][3]benzazepine L-(+)- tartarate. It is freely soluble in water and very slightly soluble in methanol.
Uses
1 INDICATIONS AND USAGE Varenicline tablets are indicated for use as an aid to smoking-cessation treatment. Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking-cessation treatment. ( 1 and 2.1 )
Dosage
2 DOSAGE AND ADMINISTRATION Begin varenicline tablets dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin varenicline tablets dosing and then quit smoking between days 8 and 35 of treatment. ( 2.1 ) Starting Week: 0.5 mg once daily on days 1-3 and 0.5 mg twice daily on days 4-7. ( 2.1 ) Continuing Weeks: 1 mg twice daily for a total of 12 weeks. ( 2.1 ) An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence. ( 2.1 ) Consider a gradual approach to quitting smoking with varenicline tablets for patients who are sure that they are not able or willing to quit abruptly.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling: Neuropsychiatric Adverse Events including Suicidality [see Warnings and Precautions (5.1) ] Seizures [see Warnings and Precautions (5.2) ] Interaction with Alcohol [see Warnings and Precautions (5.3) ] Accidental Injury [see Warnings and Precautions (5.4) ] Cardiovascular Events [see Warnings and Precautions (5.5) ] Somnambulism [see Warnings and Precautions (5.6) ] Angioedema and Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.8) ] In the placebo-controlled premarketing studies, the most common adverse events associated with varenicline tablets (>...
Interactions
7 DRUG INTERACTIONS Based on varenicline characteristics and clinical experience to date, varenicline tablets has no clinically meaningful pharmacokinetic drug interactions [see Clinical Pharmacology (12.3) ]. Other Smoking-Cessation Therapies: Safety and efficacy in combination with other smoking-cessation therapies has not been established. Coadministration of varenicline and transdermal nicotine resulted in a high rate of discontinuation due to adverse events. ( 7.1 ) Effect of Smoking Cessation on Other Drugs: Pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) may be altered, necessitating dose adjustment.
Warnings
5 WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with varenicline tablets for the occurrence of such symptoms and instruct them to discontinue varenicline tablets and contact a healthcare provider if they experience such adverse events. ( 5.1 ) Seizures : New or worsening seizures have been observed in patients taking varenicline tablets. 4 CONTRAINDICATIONS Varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline tablets. History of serious hypersensitivity or skin reactions to varenicline tablets. ( 4 )
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, capsule shaped tablets, debossed with ‘V0.5’ on one side and plain on the other side and a 1 mg white to off-white, capsule shaped tablets, debossed with ‘V1’ on one side and plain on the other side.
Frequently Asked Questions
What is Varenicline used for?▼
1 INDICATIONS AND USAGE Varenicline tablets are indicated for use as an aid to smoking-cessation treatment. Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking-cessation treatment. ( 1 and 2.1 )
What are the side effects of Varenicline?▼
6 ADVERSE REACTIONS The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling: Neuropsychiatric Adverse Events including Suicidality [see Warnings and Precautions (5.1) ] Seizures [see Warnings and Precautions (5.2) ] Interaction with Alcohol [see Warnings and Precautions (5.3) ] Accidental Injury [see Warnings and Precautions (5.4) ] Cardiovascular Events [see Warnings and Precautions (5.5) ] Somnambulism [see Warnings and Precautions (5.6) ] Angioedema and Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.8) ] In the placebo-controlled premarketing studies, the most common adverse events associated with varenicline tablets (>...
What are the important warnings for Varenicline?▼
5 WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with varenicline tablets for the occurrence of such symptoms and instruct them to discontinue varenicline tablets and contact a healthcare provider if they experience such adverse events. ( 5.1 ) Seizures : New or worsening seizures have been observed in patients taking varenicline tablets. 4 CONTRAINDICATIONS Varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline tablets. History of serious hypersensitivity or skin reactions to varenicline tablets. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.